# K980508: Keratome Blade, Chirom Model Alk 500500; Keratome Blade, S.C.M.D. Model Turokeratome 400400

- Pathway: 510(k) (Traditional)
- Applicant: Micro Specialties, Inc.
- Decided: May 1, 1998 after 80 days
- Product code: HNO (Keratome, Ac-Powered)
- Device class: 1
- Regulation: 21 CFR 886.4370
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K962661 (1996). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972727: Cbalk-1000 Blade, Howard Instruments, Inc. (1997) Summary page 2.
- K962661: ML Microkeratome Blade, Med-Logics, Inc. (1996) Summary page 2.

## Most influential descendants
- K993122: MSP M/K Blade (2000), 0 descendants of its own

## Indications for use
The Microspecialties, Inc., 500500 and 400400 keratome blades are designed for use with other manufacturer’s keratome. The 500500 blade is for use in the Chiron Keratome while the 400400 blade is used in the S.C.M.D. Keratome.

Source page: https://510kreport.com/device/K980508
Methodology: https://510kreport.com/methodology